Health Support Project for Persons With Disabilities
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 600
- 试验地点
- 1
- 主要终点
- Comprehensive health literacy
研究概览
简要总结
The goal of this clinical trial is to evaluate the health status of people with disabilities, to improve their health outcomes by providing support on nutrition, physical activity, and self-management of chronic conditions, and to strengthen sectors' capacity to deliver health management services and support for people with disabilities through a train-the-trainer program.
详细描述
In sheltered workshops (SWs) and integrated vocational rehabilitation services centers (IVRSCs) across Hong Kong, people with disabilities (PWDs) are provided with one-stop, integrated, and seamless vocational rehabilitation services in a specially designed environment. The aim is to help PWDs develop their social and economic potential to the fullest extent. Comorbid disorders - often overlooked when relevant sectors (e.g., non-government organizations) or healthcare professionals fail to look beyond disabilities - are likely to impose additional burdens on existing workload, resulting in adverse effect on their performance in areas such as productivity, health outcomes, personal well-being, and quality of life. Poor management of comorbid disorders may even lead to increased morbidity and mortality rates.
The Health Support Program (HSP) is a structured, multi-component intervention developed in close collaboration with a multidisciplinary research team of occupational therapists, physiotherapists, dietitians, and nurses from the Department of Rehabilitation Sciences and the Department of Food Science and Nutrition at The Hong Kong Polytechnic University. The program consists of three components: (1) nutrition, (2) physical activity, and (3) self-management of chronic conditions. The intervention is rooted in the Health Belief Model, and each component is developed based on international guidelines and current research findings. The HSP is tailored for PWDs with or without intellectual disabilities to improve health outcomes and is delivered with the assistance of the Digital Health Profile (DHP) System for the PWDs in the SWs and IVRSCs.
The DHP is a centralized database designed to record the health conditions of PWDs and optimize workflow management. Supported by an interactive dashboard and e-resources on health management, the core function of the DHP is to create health profiles for each PWDs, so that trained personnel from the SWs and IVRSCs can monitor and manage the health status of each PWDs more effectively and accurately. The DHP in all SWs and IVRSCs can together produce a comprehensive overview of the health conditions of PWDs in the community, which could facilitate and provide useful information for policy making.
Eligible PWDs in the SWs and IVRSCs who have at least one of the following physician-diagnosed chronic conditions: diabetes, hypertension, hyperlipidemia, cardiovascular disease, or obesity, will be recruited in a pragmatic, open-label, parallel-group, cluster-randomized clinical trial. The implementation of the HSP will be evaluated using the Reach, Effectiveness, Adoption, Implementation, Maintenance (RE-AIM) Framework.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
盲法说明
No masking strategies will be included.
入排标准
- 年龄范围
- 15 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •People with disabilities in sheltered workshops and integrated vocational rehabilitation services centers who had at least one of the following physician-diagnosed chronic conditions: diabetes, hypertension, hyperlipidaemia, cardiovascular disease, or obesity
排除标准
- •Those with severe intellectual disabilities (IQ below 35) or at imminent risk of suicide
结局指标
主要结局
Comprehensive health literacy
时间窗: Baseline, 12-week mid-intervention, 24-week post-intervention, and 6-month follow-up
Comprehensive health literacy will be measured as general knowledge of nutrition, physical exercise, and self-management of chronic diseases using a self-designed, closed-ended questionnaire. Responses will be scored as follows: 1 point for the correct answer, and 0 points for the incorrect answer or for the "Not sure" response. The dichotomized scores for each item in each area will be summed, with results ranging from 0 to 30 for knowledge of nutrition, 0 to15 for knowledge of physical activity, and 0 to 27 for knowledge of self-management of chronic diseases. For participants with intellectual disabilities, the number of items will be reduced. The results will range from 0 to 21 for knowledge of nutrition, 0 to15 for knowledge of physical activity, and 0 to 27 for knowledge of self-management of chronic diseases. Higher scores indicate better health literacy regarding nutrition, physical exercise, and self-management of chronic diseases, separately.
次要结局
- Dietary intake(Baseline, 12-week mid-intervention, 24-week post-intervention, and 6-month follow-up)
- Achievement of physical activity goals(Baseline, 12-week mid-intervention, 24-week post-intervention, and 6-month follow-up)
- Self-efficacy for physical activity(Baseline, 12-week mid-intervention, 24-week post-intervention, and 6-month follow-up)
- Body mass index (BMI)(Baseline, 12-week mid-intervention, 24-week post-intervention, and 6-month follow-up)
- Blood pressure(Baseline, 12-week mid-intervention, 24-week post-intervention, and 6-month follow-up)
- Handgrip strength(Baseline, 12-week mid-intervention, 24-week post-intervention, and 6-month follow-up)
- Medication adherence(Baseline, 12-week mid-intervention, 24-week post-intervention, and 6-month follow-up)
- Mental well-being(Baseline, 12-week mid-intervention, 24-week post-intervention, and 6-month follow-up)
- Health-related QoL(Baseline, 12-week mid-intervention, 24-week post-intervention, and 6-month follow-up)
- Productivity levels(Baseline, 12-week mid-intervention, 24-week post-intervention, and 6-month follow-up)
- Satisfaction levels(12-week mid-intervention, 24-week post-intervention)
研究者
TSANG Hector Wing-Hong
Chair Professor
The Hong Kong Polytechnic University